Clinical Data: TAIs Show Promise in Disease Modification

TauRx has evaluated its first-generation Tau Aggregation Inhibitor (TAI), rember®, in a large, double-blind, long-duration international Phase 2 clinical trial in 321 patients with mild or moderate Alzheimer’s. This study provided the first clinical indication that treatment with TAIs holds promise in modifying the progression of the disease. In the Phase 2 study, rember® showed a significant reduction in the rate of clinical decline: 80% by weeks 50 and 102 of this trial, relative to controls, as measured using psychometric tools. Functional neuroimaging results from the trial supported the psychometric data: in patients taking rember®, the loss of function in the areas of the brain known to be particularly affected by the Tau-tangle pathology of disease was eliminated over 6 months. Functional brain scan benefits seen at 6 months were predictive of clinical benefit at 12 months.

Molecular imaging (SPECT/PET) provided a key result in the Phase 2 rember® clinical trial by identifying regions within the brain that were protected by the drug. These regions coincided with areas known to be affected by Alzheimer’s neuropathology and provide significant support for the use of TAIs to treat the disease.

In the images to the left, the central figure demonstrates the locations of Tau pathology in Alzheimer’s. The surrounding images show the locations that rember® appears to protect. These images were created using data from a randomized placebo controlled trial using rCBF SPECT. The areas are the statistically significant regions of difference between the active and control groups.

In contrast, clinical studies with diverse therapies directed at Aß pathology and other targets have not demonstrated clinical benefit when evaluated in large patient populations. Indeed, in one trial, dementia persisted in patients despite levels of Aß aggregates being reduced by the therapy to non-detectable levels.